New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

05/28/2009

Trade Name:

Besivance

Generic Name or Proper Name (*):

besifloxacin ophthalmic suspension

Indications Studied:

Treatment of bacterial conjunctivitis

Label Changes Summary:

* Efficacy in pediatric patients 1 year and older has been demonstrated in controlled clinical trials * Safety and effectiveness in infants < 1 year of age have not been established * There is no evidence that the ophthalmic administration of quinolones has any effect on weight bearing joints * Information on AE profile and clinical study * New drug